Based on European Medicines Agency (EMA) regulatory procedures, the drug that did not trigger a clock stop 2 but had a list of questions in meeting highlights is Onureg (azacitidine). This happened during its 2020 review for a marketing authorization application (MAA).
Here's a breakdown of the specific scenario:
* Context: The EMA uses clock stops to pause the 210-day review timeline for a drug's MAA.
* Clock Stop 1 (Day 120): At Day 120, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a List of Questions (LoQ) for Onureg, which triggered the first clock stop.
* No Clock Stop 2 (Day 180): After the company submitted its response, the CHMP issued a List of Outstanding Issues (LoOI) at Day 180. However, this did not trigger a second clock stop because the company's response strategy to the LoOI was discussed during a Clarification Meeting. This approach allowed the review to continue without pausing the clock a second time.
* Meeting Highlights: This specific case was later highlighted by the EMA as an example of how discussions during a Clarification Meeting can address outstanding issues without the need for a second clock stop, thereby potentially shortening the overall review time.
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